Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the FDA.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Office of Regulatory Affairs

Funding Opportunity Title

ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratories (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-12-008

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

FOA Purpose

The intended outcome of this FOA is for microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs to be conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory and the goal of achieving a nationally integrated food safety system to be further advanced.  This will be accomplished by preparing the primary food testing laboratories for State manufactured food regulatory programs to achieve and maintain ISO/IEC 17025:2005 laboratory accreditation.  Currently accredited laboratories will also be prepared for accreditation enhancements.  Increased laboratory analyses from ISO/IEC 17025:2005 accredited labs, as would be accomplished through this cooperative agreement, will in effect serve to increase the analytical capacity for FDA and enhance efforts to protect the food supply.  Data generated by recipient laboratories will be made available for consideration of FDA enforcement actions as well as for surveillance purposes and during response to foodborne outbreaks through eLEXNET.  Laboratory accreditation will also assist State manufactured food regulatory programs in achieving conformance with the Manufactured Food Regulatory Program Standards (MFRPS). 

Key Dates
Posted Date

February 13, 2012

Open Date (Earliest Submission Date)

February 15, 2012

Letter of Intent Due Date

February 29, 2012

Application Due Date(s)

April 16, 2012  

AIDS Application Due Date(s)

NA

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

July 1, 2012

Expiration Date

April 17, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Program Objectives

The Foo
d and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of up to $6 million to be awarded under Limited Competition to State food testing laboratories that serve as the primary servicing laboratory for State manufactured food regulatory programs for microbiological and chemical analyses.  The intended outcome of this FOA is for microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs to be conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory and the goal of achieving a nationally integrated food safety system to be further advanced.  This will be accomplished by preparing the primary food testing laboratories for State manufactured food regulatory programs to achieve and maintain ISO/IEC 17025:2005 laboratory accreditation by an impartial and internationally recognized accrediting body.  Accredited laboratories will also be prepared for accreditation enhancements, such as accreditation for additional sections within the laboratory and other activities to expand the scope of accreditation.  Increased laboratory analyses from ISO/IEC 17025:2005 accredited labs, as would be accomplished through this cooperative agreement, will in effect serve to increase the analytical capacity for FDA and enhance efforts to protect the food supply.  Data generated by recipient laboratories will be made available for consideration of FDA enforcement actions as well as for surveillance purposes and during response to foodborne outbreaks through eLEXNET.  Laboratory accreditation will also assist State manufactured food regulatory programs in achieving conformance with Standard Ten of the Manufactured Food Regulatory Program Standards (MFRPS).   

Laboratory accreditation attests to the competency and technical capability of a laboratory to perform specific tasks.  The results generated are defensible to a recognized standard that is independent of lab personnel or other changes.  In addition, accreditation supports the traceability of technical results generated by a laboratory.   In the event of a large-scale terrorist activity or other large-scale events affecting foods or food products, States and Federal authorities can use laboratory test results from accredited laboratories to respond at once and enforce regulatory compliance to protect the safety of the food supply. 

Funding will be made specifically to eligible laboratories to achieve and maintain ISO/IEC 17025:2005 accreditation by an impartial and internationally recognized accreditation body.  Eligible laboratories currently accredited will also be able to receive funds to maintain accreditation and/or perform enhancements, such as accreditation for additional sections within the laboratory and other activities to expand the scope of accreditation.   Only proposed projects designed to obtain, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation will be considered for funding. 

The PD(s)/PI(s) will retain the primary responsibility and dominant role for planning, directing, and executing the proposed project, however, the cooperative agreement award mechanism will result in substantial involvement by the FDA.  Substantial involvement includes, but is not limited to:

1) Initial quality management system assessment and gap analysis

2) Timeline plan execution

3) Monitoring of progress through on-site visits, conference calls, emails, and other correspondence

4) Quarterly follow-up of the laboratory's progress

5) FDA training on processes

6) FDA final assessment of laboratory quality management systems

7) FDA technical and financial assistance to apply, maintain, and enhance laboratory accreditation

Successful applicants will undergo a quality management system assessment provided by the FDA, Division of Field Science (DFS).  The initial assessment will identify the gaps against the requirements of ISO/IEC 17025:2005 standard followed by the development of a plan to achieve conformance.  The plan will identify the tasks necessary to address non-conformities, responsible personnel, and timeframes to ensure accreditation is achieved, maintained, and/or enhance laboratory accreditation within the established timeframe. 

The outcomes of the work provided under this cooperative agreement are as follows:

1.  Laboratories supporting state manufactured food regulatory programs conduct chemical and microbiological analyses of food samples within the scope of ISO/IEC 17025:2005 laboratory accreditation.

2.  Strategies for achieving, maintaining, and enhancing a food testing laboratory's ISO/IEC 17025:2005 accreditation will be developed, shared, and duplicated on a national basis. 

3.  The laboratory capacity for FDA to protect the safety of the food supply will be increased and public health will be further enhanced. 

4.  Increased sharing of laboratory results generated under the scope of laboratory accreditation to promote earlier identification and regulatory response to adulterants in the food supply. 

5.  Advancement of a nationally integrated food safety system. 

Only the following laboratories will be eligible to apply: 

Laboratories that are the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of State manufactured food regulatory programs will eligible to apply.  Eligible laboratories must also participate, or agree to participate within 30 days of the award, in the Food Emergency Response Network (FERN).  These laboratories must also be developing or maintaining a quality management system that is in compliance with the managerial and technical requirements of the ISO/IEC 17025:2005 standard.   The laboratories must also agree to participate in proficiency testing programs and share laboratory results through eLEXNET.  In addition, the State manufactured food regulatory program associated with the laboratory must have a current food safety inspection contract with FDA, or agree to enter into a food safety inspection contract at the earliest possible date.  The State manufactured food regulatory program must maintain a current food contract with FDA throughout the cooperative agreement.  The State manufactured food regulatory program must also be enrolled in the MFRPS, or agree to enroll at the earliest possible date.  In addition, the State manufactured food regulatory program must maintain enrollment in the MFRPS and demonstrate progress towards conformance throughout the cooperative agreement. 

A technical review session will be held for prospective grantees in February/March 2012.  The conference call information will be provided to prospective grantees that submit a letter of intent.  The technical review session will provide an overview of the submission requirements and allow prospective grantees an opportunity to ask questions regarding the application process.  Participation in the technical review session is optional, but strongly encouraged. 

The FDA only guarantees one year of funding with the possibility of up to four years of additional, non-competitive support, contingent on performance and continued availability of federal funds.

These funds are intended to supplement, not replace, State funding for program improvement and activities. Laboratories funded under these cooperative agreements will be required to provide the previous and subsequent years of State funding to demonstrate that these funds have not replaced State allocations.

2. Background

Over the past several years, the food safety system has continually encountered risks and emergencies of significant national concern. Multiple efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.

a. President’s Food Safety Working Group

An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009. The charge of the FSWG is “To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced.” Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens surveillance and enforcement, and improves response and recovery.

Furthermore, the FSWG has committed to work to “modernize food safety by building collaborative partnerships with consumers, industry and our regulatory partners and through a transparent process, build a food safety system that will meet the challenges posed by a global food supply in the 21st century.”  These cooperative agreements will help to further achieve these goals by strengthening the food safety system in a way that will ultimately extend beyond state borders to have an impact on both national food safety and the associated international food supply.

b. National Integrated Food Safety System

FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.

c. Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods. 

FSMA directs FDA to build an integrated national food safety system in partnership with State and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities.

Specifically, TITLE II—IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS, section 202(b)(1) provides that not later than 30 months after the January 4, 2011, date of enactment of FSMA, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary.

d. Food and Drug Administration Amendments Act of 2007 (FDAAA)

FDAAA amended the FD&C Act to require FDA to work with the States to undertake activities to assist in improving food safety. Section 1004 of FDAAA states:

SEC. 1004. STATE AND FEDERAL COOPERATION

(a) IN GENERAL.—The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to—

(1) Establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.

(b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—

(1) Advisory assistance;

(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) Financial and other assistance.

(c) SERVICE AGREEMENTS.—The Secretary may, under an agreement entered into with a federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.

e. Import Safety Action Plan (ISAP)

The Import Safety Action Plan acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the ISAP provides as follows:

Federal-State Rapid Response

Recommendation 12 – Maximize Federal-State Collaboration.

The roles of and the resources used by the federal government and the States in import safety are complementary. States possess legislative authority and resources to respond to unsafe imported products within their jurisdiction. The federal government can take steps to interdict unsafe imported goods at ports-of-entry. Should an unsafe product enter domestic commerce, federal departments and agencies often work with State authorities to track it down, seize it, notify the public if it has already been purchased by consumers, and impose appropriate penalties on domestic entities who violate U.S. law. Also, both the federal government and States may have access to information relevant to protecting consumers that the other does not possess. For example, federal departments and agencies may have relevant information about the foreign source of the imported product and about the importer. This information can help State officials track down an unsafe imported product within their jurisdiction. On the other hand, State officials may identify an unsafe imported product during transport or at the point-of-sale, if the product does get into the country, and can tip-off federal officials to prevent future shipments from entering domestic commerce.

Several federal departments and agencies already collaborate closely with State authorities to protect consumers. For example, FDA has contracts and cooperative agreements with State governments to share information, conduct joint inspections, and collaborate on laboratory analyses. Greater mutual leveraging of State and federal resources can further enhance consumer protection.

12.1 Consider cooperative agreements between the federal inspection agencies and their State counterparts for greater information-sharing. Such cooperative agreements would not infringe on the statutory authorities of federal or State regulators and would encourage a coordinated effort that would result in a more rapid and effective response. Establishing clear procedures and points-of-contact for information sharing and joint enforcement efforts can further enhance the effectiveness of federal-State actions to limit exposure and potential harm to consumers if an unsafe imported product makes it into domestic commerce.

The food safety regulatory system in the United States is a tiered system that involves Federal, State, Local and Tribal governments. The Food and Drug Administration (FDA) is responsible for ensuring that all foods moving in interstate commerce, except those under United States Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly.

State agencies conduct inspection and regulatory activities that help ensure that safe food is produced, processed, or sold within their jurisdictions. Many State agencies also conduct food plant inspections under contract with the FDA. These inspections are performed under the States' laws and authorities or the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or both. To maximize the use of resources among the FDA and the State governments, particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect.

In June 2000, the Department of Health and Human Services' Office of the Inspector General (OIG) released a report of FDA's oversight of State contracts. In this report, the OIG recommended that FDA take steps to promote "equivalency among Federal and State food safety standards, inspection programs, and enforcement practices." In response to their findings, FDA established a committee to develop a set of quality standards for manufactured food regulatory programs. The committee was comprised of officials from FDA and from State agencies responsible for the regulation and inspection of food plants.

The Manufactured Food Regulatory Program Standards (MFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants. The elements of the program standards describe best practices of a high-quality regulatory program. Achieving conformance with them will require comprehensive self-assessment on the part of a State program and will encourage continuous improvement and innovation.

The program standards are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from food borne illness and injury. These elements include the program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, food borne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment.

FDA will use the program standards as a tool to improve contracts with jurisdictions. The program standards will assist both FDA and the State jurisdictions in fulfilling their regulatory obligations. FDA recognizes that full use and conformance of the program standards by State jurisdictions will take several years. Such jurisdictions will, however, be expected to implement improvement plans to demonstrate that they are moving toward full conformance. The goal is to implement a risk-based food safety program by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The development and conformance of these program standards will help Federal and State programs better direct their regulatory activities at reducing foodborne illness hazards in food plants. Consequently, the safety and security of the United States food supply will improve.

Leads: HHS / FDA, USDA, CPSC, EPA Time Frame: Long Term

12.2 Review admissibility policies to improve the use of evidence and laboratory results from State investigations of imported products. Currently, there are limitations on the use of State-developed evidence in federal court cases due to the gathering, analysis and retention of such evidence by non-federal government entities. Being able to use this evidence would make it easier for federal departments and agencies to take enforcement actions against bad actors.

Leads: DOJ, HHS / FDA, USDA, CPSC Time Frame: Short Term

FDA is offering these cooperative agreements to laboratories supporting State manufactured food regulatory programs to achieve, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation.  Laboratory accreditation also supports state manufactured food regulatory programs in achieving conformance with the Manufactured Food Regulatory Program Standards (MFRPS), Standard 10.  Laboratory accreditation will contribute to production of accurate and reliable test data and as a result a quicker acceptance of analytical results by FDA and other regulatory agencies for enforcement actions, surveillance purposes and during response to foodborne outbreaks.  

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications.

FDA intends to fund an estimate of 20 - 30 awards, corresponding to a total of up to $6,000,000, for fiscal year 2012. Future year amounts will depend on annual appropriations.  

FDA intends to commit up to $6,000,000 in FY 2012.

Awards of no more than $300,000 per year for laboratories seeking to obtain ISO/IEC 17025:2005 accreditation will be given. 

Awards of no more than $150,000 per year for currently accredited laboratories seeking to maintain and enhance the scope of ISO/IEC 17025:2005 laboratory accreditation will be given.

Award is contingent upon FDA appropriations, and the submission of a meritorious application.  Future year amounts will depend on annual appropriations and performance.

Award Budget

Application budgets are limited to up to $300,000 (direct and indirect costs) per year for laboratories seeking to obtain ISO/IEC 17025:2005 accreditation but need to reflect actual needs of the proposed project.

Application budgets are limited to up to $150,000 (direct and indirect costs) per year for currently accredited laboratories seeking to maintain and enhance the scope of ISO/IEC 17025:2005 laboratory accreditation but need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application requesting support may not exceed five years. 

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Governments

State Governments - This opportunity is only available to State food safety laboratories that meet the following criteria:

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit only one application.   

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:  

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, the electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

These awards may only be used for:

Achieving, maintaining, and/or enhancing laboratory ISO/IEC 17025:2005 accreditation in laboratories that are the primary chemical and microbiological servicing laboratories for State manufactured food regulatory programs, as described in Section III.1 Eligible Applicants.

Allowable costs:

1) Consultant services

2) Employee salaries, wages and fringe benefits

4) Rental, purchasing, calibration, installation and maintenance of equipment

5) Indirect costs

6) Recruitment costs for hiring new employees

7) Registration fees

8) Purchase or development of IT equipment, software, and support

9) Shipping and mailing of equipment and supplies

10) Travel (must not exceed coach class fare)

11) Speaker fees

12) Accreditation fees

13) Training courses and materials

14) Laboratory and office supplies

15) Office supplies

Non-allowable costs:

1) Facilities and work covered under current FDA food safety inspection contracts cannot be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement.  The State must be able to account separately for fund expenditures un der the food safety inspection contracts and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Subcontracting to third parties is limited to 25% of each year's award.

4) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

Funding Plan:

Funding for years 2 - 5 will be noncompetitive continuation of support and depend on performance, program progress, and the availability of Federal funds.

Funds should be requested in the budget to travel to meetings with FDA program staff about the progress of the project and for training. A portion of budgeted travel funds should be set aside for key personnel to attend the annual face-to-face FERN meeting and have key personnel to attend on-site visits by FDA.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Office of Regulatory Affairs, FDA. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the ORA Project Officer by email at Wendy.Campbell@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

The applicant must specifically address the ability to achieve the following objectives in the cooperative agreement:

1)  Demonstrate the ability to implement and maintain a quality management system that is in compliance with the managerial and technical requirements of ISO/IEC 17025 and is accredited by an impartial, independent, and internationally recognized accreditation body;. 

2)  Demonstrate the ability to fully participate in initiatives supporting the ISO/IEC 17025:2005 accreditation process and FERN activities, such as an annual face-to-face meeting, monthly conference calls, sharing of best practices, on-site visits, and program audits; 

3)  Demonstrate the ability to share all laboratory data generated related to food safety through eLEXNET and as requested by the FDA.  Ideally, an electronic data exchange will be established between the laboratory information management system (LIMS) and eLEXNET;      

4)  Demonstrate the availability of adequately trained food program and/or laboratory staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement;

5)  Provide a properly detailed budget (one for each of the five years) that is intended achieve, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation;

6)  Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement;

7)  Provide the previous year and current funding level certification for the laboratory program from State funding appropriations;

8)  Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work and program sustainability, as described in this announcement;

9)  Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs;

10)  Capability to analyze food samples for chemical and microbiological hazards utilizing analytical methods within the scope of accreditation for emergency response and surveillance efforts - an annual estimate of capability should be provided for chemical and microbiological testing; 

11)  Summary description of procedures or processes in place to evaluate the process for preparing for accreditation;

12)  Summary description of procedures in place to monitor accreditation requirements, including the tracking and monitoring of activities and training in progress to include a description of the laboratory quality manual and technical requirements process and procedures. 

Laboratories applying for funding through this FOA must provide a complete description of the facilities, personnel qualifications, management practices, organization, and a commitment to analyze samples in their application to include the following: 

1)  Operational support areas to be used for the project, including floor diagrams of the laboratories, details about the availability of ancillary laboratory safety, and support equipment and facilities;

2)  Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures;

3)  Detailed description of laboratory access procedures, including a description of practices and system which limit access to laboratory space by unauthorized personnel to include measures in place to ensure that all staff have sufficient clearance and/or background checks to work on this project or program;

4)  Qualifications of all personnel that will be assigned to the project, including the quality assurance (QA)/quality control (QC) manager, QA/QC personnel, and laboratory technical personnel;

5)  Complete description of the laboratory staffing management and structure, food testing capabilities, policies, procedures, personnel, technical operations, and support services. Provide an organizational chart indicating all reporting relationships and responsibilities; 

6)  A detailed description of the proposed upgrades to existing laboratory facilities to accommodate new equipment, including drawings and cost estimates;

7)  A summary description of any quality management system in place or under development as it relates to quality control and quality assurance procedures and practices;

8)  A summary description of procedures in place to monitor food sample workflow, including the tracking and monitoring of sample analyses in progress, including a description of the laboratory work product review process and how reports of sample analyses will be provided within reasonable timeframes;

9)  Previous year and current funding level certification for the laboratory program from State funding appropriations. 

Project milestones for laboratories seeking ISO/IEC 17025:2005 accreditation:

Year 1: 

1.  All key laboratory staff are familiar with the requirements for implementation and maintenance of the ISO/IEC 17025:2005 standard.  Training records required by ISO/IEC 17025:2005 are developed as well as a training plan for ongoing training to accomplish accreditation.

2.  Staffing an independent quality manager position in the laboratory organization that is qualified and trained in QMS and ISO/IEC 17025:2005. The funded laboratory will submit the contact information of the quality manager that shall be the point of contact for quality management system reports and communication with FDA.

3.  Enroll in suitable proficiency testing program(s) and document a four-year proficiency testing plan for meeting the minimum proficiency testing/calibration participation requirements.

4.  Laboratory enrolls in the FERN and participates in conference calls, attends conferences, and supports FERN activities. 

5.  Participation in an on-site lab assessment by the FDA Division of Field Sciences and establish a timeline/plan of incremental steps to accreditation.

6.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET. 

Years 2 - 3:

1.  Create and implement a Quality Manual and Management System policies and procedures that meets ISO/IEC 17025:2005 requirements.

2.  Conduct at least one internal audit and management review per year to identify non-conformances. 

3.  Develop an improvement plan to address each non-conformance, including key personnel responsible, timelines, and tasks. 

4.  Requirements for all suitable proficiency testing are met. 

5.  Active participation in the FERN continues. 

6.  Participation in on-site lab assessments by FDA to determine progress to accreditation, and work with FDA to establish a timeline/plan of incremental steps to accreditation.

7.  Adequate training for laboratory to meet the requirements of ISO/ISE 17025:2005 accreditation and to keep abreast of scientific and technological advances in relevant areas.

8.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET. 

Year 4. 

1.  Submit completed application to accrediting body to initiate an assessment of the organization.

2.  Assessment, or pre-assessment, is conducted by the accrediting body. 

3.  Laboratory addresses any areas of non-conformance or deficiencies noted by responding with a written corrective action response. 

4.  Requirements for all suitable proficiency testing are met. 

5.  Active participation in the FERN continues. 

6.  Adequate training for laboratory to keep abreast of scientific and technological advances in relevant areas.

7.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

Year 5. 

1. Accreditation is granted by the accrediting body. 

2. Laboratory submits a plan including the designation of personnel, resources, and funding necessary to maintain accreditation for five years beyond the cooperative agreement program period.  Laboratories are also encouraged to include plans to enhance the scope of accreditation, in consultation with the State manufactured food regulatory program, feed program (if applicable), and the FDA.  These accreditation enhancements may include accreditation for additional sections within the lab and expansion of the number and/or type of methods. 

3.  Active participation in the FERN continues. 

4.  Adequate training for laboratory to keep abreast of scientific and technological advances in relevant areas.

5.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

For laboratories currently ISO/IEC 17025:2005 accredited

Year 1. 

1.  Actively participate in the FERN, including meetings, conference calls, and other activities. 

2.  In conjunction with the State manufactured food regulatory program, feed program (if applicable), and the FDA, identify areas to enhance the scope of accreditation.

3.  Participate in a mentoring program to assist other laboratories in achieving ISO/IEC 17025: 2005 accreditation. 

4.  Maintain current ISO/IEC 17025:2005 accreditation. 

5.  Implement a training program for the laboratory to keep abreast of scientific and technological advances in relevant areas.

6.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET. 

Years 2 - 5

1.  Enhance the scope of accreditation in consultation with the State manufactured food regulatory program, feed program (if applicable), and the FDA.  These accreditation enhancements may include accreditation for additional sections within the lab and expansion of the number and/or type of methods. 

2.  Continue to actively participate in the FERN. 

3.  Continue to participate in a mentoring program to assist other laboratories in the cooperative agreement in achieving ISO/IEC 17025:2005 accreditation by the end of Year 5. 

4.  Continue to maintain ISO/IEC 17025:2005 accreditation, which includes conducting an annual surveillance audit, continuous update and improvement of the Quality Manual and Management System policies and procedures, and a three year full system audit required for renewal. 

5.  Maintain training for the laboratory to keep abreast of scientific and technological advances in relevant areas.

6.  Laboratory submits a plan including the designation of personnel, resources, training, and funding necessary to maintain accreditation for five years beyond the cooperative agreement program period.

7.  All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in HHS Grants Policy Statement

Acceptable post submission materials include:

Section V. Application Review Information

1. Criteria

All applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.

For this particular announcement, note the review criteria described below (Criteria 1-3) will be considered in the review process.

1. The rationale and design to meet the goals and project milestones of the cooperative agreement (total weight = 60%);

2. Have adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (weight = 20%);

3. Demonstration that capabilities that can be sustained in the long-term (five years after the conclusion of the project period; expected challenges should be documented and addressed). This includes plans to achieve the incorporation of project-developed capabilities into long-term program work (weight = 20%).

Note:  Only the criteria and scoring described above will be used for scoring during the review of applications for this announcement.  Reviewers may consider the additional criteria described under "Overall Impact" (below) as they relate to the criteria described above, but separate scores will not be give for the items described below.  

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the preceding review criteria and additional review criteria (as applicable for the project proposed).

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel, in accordance with HHS peer review policy and procedures, using the stated review criteria.  

As part of the scientific peer review, all applications:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will receive a copy of his or her Summary Statement (written critique). 

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for HHS Grants website.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

Support will be in the form of a cooperative agreement.  Substantive involvement by the awarding agency is inherent in the cooperative agreement award.  Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement. 

Substantive involvement includes, but is not limited to, the following:

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur.  There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.  Monitoring of the recipient should demonstrate that the laboratory is achieving the goals of the cooperative agreement and proposal. 

The purpose of these cooperative agreements is to advance efforts for a nationally integrated food safety system by assisting laboratories that provide laboratory support to State manufactured food regulatory programs to achieve, maintain, and enhance laboratory accreditation.  

The following conditions of the award will apply to all funded applicants and must be maintained throughout the cooperative agreement. 

1.  The laboratory must remain the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of the State manufactured food regulatory program to be eligible to apply and receive funds through this cooperative agreement. 

2.  The laboratory must maintain active participation in the Food Emergency Response Network (FERN). 

3.  The laboratories must successfully participate in proficiency testing programs and share laboratory results through eLEXNET. 

4.  In addition, the State manufactured food regulatory program supported by the laboratory must maintain a food safety inspection contract with FDA. 

5.  The State manufactured food regulatory program must also maintain enrollment in the MFRPS and demonstrate progress towards achieving conformance with the MFRPS. 

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Mid-year reports must contain the elements below as applicable to their proposal and award, but are not limited to, the following:

1)  An updated improvement plan demonstrating significant progress towards implementing a quality management system that will result in the laboratory receiving ISO/ISE 17025:2005 accreditation for laboratories seeking ISO/IEC 17025:2005 accreditation within the established timeframe.  For laboratories currently accredited, an updated improvement plan for enhancing the scope of accreditation and maintaining accreditation within the established timeframes.     

2)  A proficiency testing plan and results of participation in a recognized proficiency testing program(s) to ensure and demonstrate the quality of the tests performed in the lab.

3)  Hiring of new personnel and training of personnel in the implementation and maintenance of a quality system to achieve, maintain, and/or enhance ISO/IEC 17025:2005 accreditation.  The program must include initial and ongoing training to ensure consistent quality and continuous improvement, including assisting laboratory personnel in maintaining current knowledge of scientific and technological advances in relevant areas.

4)  Summary report on the facility inventory that is maintained by the laboratory.

5)  Status report on the installation and operational rea diness of any analytical equipment that is purchased.

6)  Summary of laboratory data shared with FDA and other regulatory agencies, including any regulatory actions taken by FDA or another regulatory agency or any significant laboratory findings that advanced the protection of public health.

7) Current funding level certification for the laboratory program from State funding appropriations.

All recipients must file a final program progress report, FSR, invention Statement, and disposition of equipment Statement within 90 days after the en d date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project, and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project.  An audit by an independent accrediting body should confer ISO/ISE 17025:2005 accreditation upon the laboratory.  The final program progress report should also detail the strategy, including commitment of personnel, resources, and funding, for maintaining of ISO/ISE 17025:2005 accreditation after the completion of the project. 

Monitoring Activities

The program project officer and technical advisor will monitor award recipients periodically.  The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer/technical advisor and the principal investigator.  In addition, periodic site visits with officials of the recipient organization may also occur to assess progress with achieving, maintaining, or enhancing the scope of ISO/IEC 17025:2005 accreditation for the laboratory.  The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations.  Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Project Officer and Technical Advisor.

The scope of the recommendation will confirm that:

1) There has been acceptable progress on the project; 2) there is continued compliance with all FDA regulatory requirements; 3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the laboratory requirements as well as security background screening.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Wendy Campbell
Project Officer
Food & Drug Administration
Office of Regulatory Affairs, Division of Federal-State Relations
Phone:  615-310-0483
Email: Wendy.Campbell@fda.hhs.gov 

Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov 

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Wendy Campbell
Food & Drug Administration
Office of Regulatory Affairs, Division of Federal-State Relations
Telephone: 615-310-0483
Email: Wendy.Campbell@fda.hhs.gov

Peer Review Contact(s)

NA

Financial/Grants Management Contact(s)

Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: Oluyemisi.Akinneye@fda.hhs.gov

Section VIII. Other Information

Recently issued HHS policy notices may affect your application submission. A full list of policy notices published by HHS is provided in the HHS Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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